Data / Medical devices / China / Sinol Dental Limited
Sinol Dental Limited: FDA-registered device maker in Xianyang Shaanxi, China, 3 510(k) clearances
Sinol Dental Limited is registered with the FDA (registration 3007031016) in Xianyang Shaanxi, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 26, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007031016
- Address
- No.3 Biyuan Road, Xianyang Shaanxi, China, 712000
- Owner or operator
- SINOL DENTAL LIMITED (10025657)
- Roles
- Manufacturer
- First device listed
- April 28, 2008
- Registered through
- 2026
- Brand names listed
- Dental Chair, Dental Light, Dental Low Spped Handpiece includin, Dental Stool, Dental Unit with Chair, High Speed Air Turbine Handpiece Se
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair And Table, Medical | KMN | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Dental, Without Operative Unit | NRU | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2013 | K130410 | DENTAL UNIT WITH CHAIR | EIA | Substantially Equivalent | Xianyang North West Medical Instrument (Group) Co. | accessdata.fda.gov |
| April 22, 2010 | K093971 | DENTAL HANDPIECE | EFB | Substantially Equivalent | North West Medical Instrument (Group) Co., Ltd. | accessdata.fda.gov |
| April 4, 2008 | K080438 | DENTAL UNIT WITH CHAIR | EIA | Substantially Equivalent | North West Medical Instrument (Group) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental
- All makers of Light, Operating, Dental
- All makers of Chair And Table, Medical
- All makers of Handpiece, Air-Powered, Dental
- All makers of Chair, Dental, Without Operative Unit
Updated July 26, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.